Cleared Special

K112738 - ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE

K112738 is an FDA 510(k) clearance for ANDON HEALTH CARE MANAGEMENT SYSTEM SOF..., manufactured by Andon Medical Co., Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 10-day FDA review.

K112738 · Andon Medical Co., Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
10d
Days
Class 2
Risk

K112738 is an FDA 510(k) clearance for the ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Andon Medical Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on September 30, 2011 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112738

510(k) Number K112738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date September 30, 2011
Days to Decision 10 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 89d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 513
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K112738 · ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
Download PDF FDA Summary Andon Medical Co., Lt…